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Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive treatment group | Experimental | The intensive treatment group will pass a life-style intervention program including consequent escalation of measures to reach sustained reduction of 10% of initial body weight at minimum. |
|
| Standard treatment group | No Intervention | Patients will be taken care of by general physician without lifestyle program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Life style change and weight reduction | Behavioral | Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism | Diabetes risk Glycated hemoglobin >5.7%, Cardiovascular risk score >5%, Hypogonadism score increase of 20 points | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Males diagnosed with metabolic syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Linn, MD | Contact | +49 641 985 57017 | thomas.linn@innere.med.uni-giessen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Justus Liebig University | Recruiting | Giessen | Germany |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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The outcomes assessor will receive pseudonymous data
| D009750 |
| Nutritional and Metabolic Diseases |